Clinical trials: sponsored by Acerta Pharma BV
NHL, DLBCL
Platform Study for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (PRISM Study)
This is a Phase 1 platform protocol designed to evaluate various targeted agents for the treatment of relapsed/refractory aggressive Non-Hodgkin's Lymphoma (NHL).
- Conditions
- NHL, DLBCL, Non-hodgkin's Lymphoma, Diffuse Large B Cell Lymphoma
- Trial name
- PRISM (NCT03527147)
- Testing
- AZD9150, Acalabrutinib, AZD6738
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Acerta Pharma BV
Healthy Volunteers
A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants
This study will evaluate the effect of fluconazole and isavuconazole on the PK of acalabrutinib and its active metabolite, ACP-5862.
- Trial name
- NCT05140096
- Testing
- Acalabrutinib, Fluconazole, Isavuconazole
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
COVID-19
Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19
Study D822FC00005 will investigate the Phamacokinetics, Safety and tolerability of Acalabrutinib suspension when delivered via a nasogastric tube and co-administered with a Proton Pump Inhibitor, in the treatment of COVID-19.
- Trial name
- NCT04497948
- Testing
- Acalabrutinib
- Where
- 4 sites in Brazil
- Volunteers
- 9 people
- Sponsor
- Acerta Pharma BV
Hepatic Impairment, Hepatic Insufficiency
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.
- Conditions
- Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT03968848
- Testing
- acalabrutinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Participants
A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196
The study will evaluate one-way interaction of calcium carbonate, omeprazole, or rifampin on ACP-196.
- Trial name
- NCT04914936
- Testing
- ACP-196, Calcium carbonate, Omeprazole
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Volunteers
A Study to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics (PK) in Healthy Adult Participants
This study will evaluate the effect of gastric pH on acalabrutinib pharmacokinetics in healthy participants.
- Trial name
- NCT04905043
- Testing
- Acalabrutinib, SmartPill®
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Participants
A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, Food Effects, and Drug-drug Interactions of ACP-196 in Healthy Participants
This study is to evaluate the safety, pharmacokinetics/pharmacodynamics (PK/PD), food-effect, and drug-drug interaction study of ACP-196 in healthy participants.
- Trial name
- NCT04901923
- Testing
- ACP-196, Itraconazole
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Volunteers
A Study to Evaluate the Effect of [14C]Acp-196 (Acalabrutinib) in Healthy Adult Participants
This study is to determine the absolute bioavailability of oral acalabrutinib and intravenous (IV) PK of [14C]ACP-196.
- Trial name
- NCT04898101
- Testing
- Acalabrutinib, Microtracer [14C]ACP-196
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Volunteers
A Study to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics (PK) of ACP-196 Alone and Coadministered With Omeprazole
This study will evaluate the effect of an acidic formulation of Acalabrutinib (ACP-196), acidic beverage, or grapefruit Juice on the PK of ACP-196 alone and coadministered with omeprazole.
- Trial name
- NCT04876807
- Testing
- ACP-196, Omeprazole
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Hepatic Insufficiency
A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196
The study will evaluate the influence of hepatic insufficiency on the PK of ACP-196.
- Trial name
- NCT04867941
- Testing
- ACP-196
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Healthy Volunteers
A Study to Evaluate the Effect of ACP-196 on the Heart Rate-corrected QT Interval in Healthy Adult Participants
This study is to evaluate the effects of single therapeutic and supratherapeutic oral doses of ACP-196 on the heart rate-corrected QT interval using Fridericia's formula (QTcF).
- Trial name
- NCT04867980
- Testing
- ACP-196, Moxifloxacin 400 mg
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
DLBCL, Richter Syndrome
A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies
This study evaluates the safety of acalabrutinib and vistusertib when taken in combination.
- Trial name
- NCT03205046
- Testing
- acalabrutinib, vistusertib
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Acerta Pharma BV
Multiple Myeloma (MM)
An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma
To characterize the safety profile of acalabrutinib with and without dexamethasone in subjects with relapsed or refractory Multiple Myeloma (MM)
- Trial name
- NCT02211014
- Testing
- acalabrutinib
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 27 people
- Sponsor
- Acerta Pharma BV
Metastatic Pancreatic Cancer
ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer
- Trial name
- KEYNOTE144 (NCT02362048)
- Testing
- ACP-196, ACP-196 in combination with pembrolizumab
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Acerta Pharma BV
Ovarian Cancer
Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)
To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian cancer
- Trial name
- NCT02537444
- Testing
- Acalabrutinib, acalabrutinib and pembrolizumab combination
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Acerta Pharma BV
Carcinoma, Non-Small-Cell Lung
Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer
Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.
- Trial name
- KEYNOTE166 (NCT02448303)
- Testing
- Pembrolizumab, Acalabrutinib
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Acerta Pharma BV
Squamous Cell Carcinoma of the Head and Neck
Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma
Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.
- Trial name
- KEYNOTE147 (NCT02454179)
- Testing
- pembrolizumab, Acalabrutinib
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Acerta Pharma BV
Metastatic Urothelial Carcinoma
Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer
Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Metastatic Urothelial Cancer
- Trial name
- KEYNOTE143 (NCT02351739)
- Testing
- pembrolizumab, ACP-196 in combination with pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 78 people
- Sponsor
- Acerta Pharma BV
Metastatic Pancreatic Cancer
Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer
To evaluate the safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects with previously untreated metastatic pancreatic cancer using standard response criteria
- Trial name
- NCT02570711
- Testing
- ACP-196, Nab-paclitaxel, Gemcitabine
- Where
- 10 sites in United States
- Volunteers
- 3 people
- Sponsor
- Acerta Pharma BV
Rheumatoid Arthritis
ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
- Trial name
- NCT02387762
- Testing
- acalabrutinib
- Where
- 17 sites in United States
- Volunteers
- 31 people
- Sponsor
- Acerta Pharma BV